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Spike 1.8 Mmols/liter Potassium 36.83X, 18.71gm

Haemodialysis Concentrate (Spikes)

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412208
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPK-116-18.71
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: Spain
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 17.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

SL-Bag

Sodium Bicarbonate I.P./E.P./USP

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183411829
Basic UDI-DI: 890618341SLHC00BPBDM
Reference: SL2-SB-500
EMDN: F040201
EMDN description: DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER
First on market country: Spain
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 17.07.2026 05:55

Manufacturer products Authorised representative products Authorised representative actors View details

08906183410136

Concentrated Haemodialysis Solution

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183410136
Basic UDI-DI: 890618341SLHC00AL2D
Reference: SL2-A-001
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: Spain
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 17.07.2026 05:55

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DIASOL ACIDIC BICARBONATE HEMODIALYSIS SOLUTION

DIASOL C45005 Acidic Bicarbonate Hemodialysis Solutions

Class IIbMDDOn the marketSingle use

Manufacturer: FARMASOL TIBBİ ÜRÜNLER SAN. VE TİC. A.Ş.
Manufacturer SRN: TR-MF-000018494
UDI-DI: D-69765800001Q5D8
Basic UDI-DI: B-69765800001Q5D8
Reference: C45005
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: Türkiye
Authorised representative: -
Last updated: 17.07.2026 04:18

Manufacturer products View details

Sansin

type: SXG-F with composition SXG-F-A (weight 1284.5g, 1751.6g, 2335.2g, 5838.6g, 11677.3g) and composition SXG-F-B(Weight 588g, 700g, 1008g, 2520g, 5040g)

Class IIbMDDOn the marketSingle use

Manufacturer: Jiangxi Sanxin Medtec Co., Ltd.
Manufacturer SRN: CN-MF-000018456
UDI-DI: 66945060593931
Basic UDI-DI: B-66945060593931
Reference: SXG-F-A 2335.2g
EMDN: F040201
EMDN description: DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER
First on market country: Bulgaria
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 17.07.2026 03:40

Manufacturer products Authorised representative products Authorised representative actors View details

Sansin

SXG-F-B 02

Class IIbMDDOn the marketSingle use

Manufacturer: Jiangxi Sanxin Medtec Co., Ltd.
Manufacturer SRN: CN-MF-000018456
UDI-DI: 56945060593934
Basic UDI-DI: B-56945060593934
Reference: SXG-F-B 02 700g
EMDN: F040201
EMDN description: DIALYSIS CONCENTRATES, BASIC SOLUTIONS, POWDER
First on market country: Bulgaria
Authorised representative: Luxus Lebenswelt GmbH
Last updated: 17.07.2026 02:40

Manufacturer products Authorised representative products Authorised representative actors View details

42607708255242

ECOCart

Class IIbMDDOn the marketSingle use

Manufacturer: Intermedt Medizin & Technik GmbH
Manufacturer SRN: DE-MF-000006369
UDI-DI: 42607708255242
Basic UDI-DI: B-42607708255242
Reference: 5506
EMDN: F0499
EMDN description: DIALYSIS CONCENTRATES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 17.07.2026 01:43

Manufacturer products View details

42607708226464

ECOCart

Class IIbMDDOn the marketSingle use

Manufacturer: Intermedt Medizin & Technik GmbH
Manufacturer SRN: DE-MF-000006369
UDI-DI: 42607708226464
Basic UDI-DI: B-42607708226464
Reference: 3708
EMDN: F0499
EMDN description: DIALYSIS CONCENTRATES - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 17.07.2026 01:43

Manufacturer products View details

PowderHemo K2GCa1,75Ac3 Powder Acidic Haemodialysis Concentrate

PowderHemo K2GCa1,75Ac3

Class IIbMDDOn the marketSingle use

Manufacturer: FARMASOL TIBBİ ÜRÜNLER SAN. VE TİC. A.Ş.
Manufacturer SRN: TR-MF-000018494
UDI-DI: 08697658020775
Basic UDI-DI: B-08697658020775
Reference: PowderHemo K2GCa1,75Ac3
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: Türkiye
Authorised representative: -
Last updated: 16.07.2026 23:15

Manufacturer products View details

08906183410143

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183410143
Basic UDI-DI: 890618341SLHC00AL2D
Reference: SL2-A-002
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Spike 0.25 Mmols/liter Calcium 45X, 16.5gm

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412512
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPC-313-16.5
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:48

Manufacturer products Authorised representative products Authorised representative actors View details

Spike 0.25 Mmols/liter Calcium 45X, 8.25gm

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412505
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPC-313-8.25
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Spike 0.25 Mmols/liter Calcium 45X, 6.24gm

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412499
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPC-313-6.24
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Spike 2.0 Mmols/liter Potassium 45X, 67.1gm

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412482
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPK-312-67.1
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Spike 2.0 Mmols/liter Potassium 45X, 33.55gm

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412475
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPK-312-33.55
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Spike 2.0 Mmols/liter Potassium 45X, 25.36gm

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412468
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPK-312-25.36
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Spike 1.0 Mmols/liter Potassium 45X, 33.6gm

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412451
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPK-311-33.6
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:47

Manufacturer products Authorised representative products Authorised representative actors View details

Spike 1.0 Mmols/liter Potassium 45X, 16.8gm

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412444
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPK-311-16.8
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Spike 1.0 Mmols/liter Potassium 45X, 12.70gm

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412437
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPK-311-12.7
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details

Spike 0.25 Mmols/liter Calcium 35X, 12.9gm

Class IIbMDR 2017/745On the marketSingle use

Manufacturer: Surni Labs
Manufacturer SRN: IN-MF-000041295
UDI-DI: 08906183412420
Basic UDI-DI: 890618341SLHC00BPKE7
Reference: SL2-SPC-221-12.9
EMDN: F040101
EMDN description: DIALYSIS CONCENTRATES, ACID SOLUTIONS, NON-STERILE
First on market country: -
Authorised representative: OMC NI MEDICAL LIMITED
Last updated: 16.07.2026 22:46

Manufacturer products Authorised representative products Authorised representative actors View details